Essure, introduced in 2002 and approved by the Food and Drug Administration (FDA), was the first non-surgical, permanent birth control method available to women. This device was classified as a Class III medical device and approved through the FDA’s Pre-Market Approval Process. In 2016, the FDA required Bayer, the manufacturer of Essure, to conduct a post-market surveillance study to gather additional data on the safety and effectiveness of the device. Before Essure’s approval, the only option for permanent birth control was tubal sterilization, a procedure that involves partial or complete removal or blockage of the fallopian tubes using rings or clips. Unlike Essure, these methods were more invasive and often associated with longer recovery periods and increased post-surgical discomfort.
The Essure device consists of microinserts made of a stainless steel inner coil, a nickel-titanium outer coil, and fibers of polyethylene terephthalate (PET). These microinserts are placed in the fallopian tubes using a minimally invasive hysteroscopic procedure, which typically takes about ten minutes and can be performed in an outpatient setting. Over a period of 12 weeks following insertion, the PET fibers stimulate the formation of scar tissue, which creates a natural barrier that blocks the fallopian tubes and prevents pregnancy. To confirm successful placement and tube closure, a hysterosalpingogram is performed several months after the procedure.
While Essure was marketed as a convenient and less invasive alternative to traditional tubal sterilization, many women experienced adverse effects. Reported complications included chronic pelvic pain, uterine perforation, fallopian tube rupture, device migration to other organs, and systemic symptoms such as hair loss, bloating, and allergic reactions. The reported incidence of these side effects ranged from 1.1% to 4.2%. In some cases, improper placement of the device was identified as the cause of these issues. In 2015, the FDA Obstetrics and Gynecology Device Panel recommended that Essure implants be removed if they were improperly positioned, caused significant pain, or triggered hypersensitivity reactions.
For women seeking removal of their Essure implants due to complications or side effects, several options are available, including hysteroscopic removal, laparoscopic extraction, and open laparotomy. Depending on the extent of complications, removal may involve bilateral salpingectomy (removal of the fallopian tubes) or, in more severe cases, a complete hysterectomy.
Many women with Essure implants have sought removal due to severe side effects, including chronic pelvic pain, perforation of the fallopian tubes, vaginal bleeding, and allergic reactions.
Dr. Sidiq Aldabbagh specializes in the minimally invasive laparoscopic removal of Essure implants. If you are experiencing complications or would like to explore removal options, please contact our office to schedule a consultation.
